Clinical Trials
Several clinical trials evaluate oleanolic acid across Phase 1 and Phase 2 studies, focusing on conditions such as insulin resistance, metabolic syndrome, and type 2 diabetes mellitus, alongside pharmacokinetic bioavailability assessments and endodontic applications targeting microbiota and inflammatory cytokines. Sponsored primarily by academic and public institutions—including the Spanish National Research Council, Universidad de Granada, University Hospital Basel, and Mansoura University—these investigations encompass both completed and active, non-recruiting protocols.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07534943 | ACTIVE_NOT_RECRUITING | Intracanal Medicaments; Inflammatory Cytokines; Endodotic Microbiota |
Mansoura University |
2026-03-01 | |
| NCT06030544 | ACTIVE_NOT_RECRUITING | Diabetic Patients; Type II Diabetes Mellitus |
Spanish National Research Council |
2022-02-25 | PHASE2 |
| NCT05529953 | COMPLETED | Healthy Subjects; Bioavailability |
Spanish National Research Council |
2021-03-15 | |
| NCT05049304 | COMPLETED | Insulin Resistance; Metabolic Syndrome |
Universidad de Granada |
2020-01-01 | |
| NCT01674946 | COMPLETED | Echolocation |
University Hospital, Basel, Switzerland |
2011-09 | PHASE1 |
(data from https://clinicaltrials.gov, updated on 2026-04-16)
Compliance for Clinical Use
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).